Director Regulatory Affairs Advertising & Promotion Job at Mediabistro in San Di

Liaises with FDA's Office of Prescription Drug Promotion (OPDP) for Advertising and Promotion submissions and works with development teams as concerns the construct of proposed labeling for regulatory submissions according to product data and Acadia objectives.Primary ResponsibilitiesLeads the development and oversight of the processes and procedures relevant to the creation, review and approval of advertising and promotional materials as part of Acadia Medical, Legal and Regulatory review process and other external communication to ensure regulatory compliance.Reviews external communications materials, sales and marketing materials, including training, for compliance to current regulations and guidance.Represents the regulatory department with senior management on regulatory strategy and risk analysis as it relates to Acadia’s commercial strategy and compliance.Participates in training for sales and marketing on advertising and promotional material.Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities.Education / Experience / SkillsBachelor’s degree in a scientific discipline or related field. An equivalent combination of relevant education and experience may be considered.Key SkillsExperience communicating and negotiating directly with OPDP and performing risk assessment.Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk / benefit to senior management, and influencing organizational direction as it pertains to compliance advertising and promotion materials.Experience with labeling development and life-cycle management.Experience involving complex negotiations with regulatory authorities.Experience in organizational management, including matrix management of senior professionals and higher-level project teams.Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development.Demonstrated problem solving abilities and conflict resolution skills.Excellent verbal and written organizational and communication skills; Experience influencing and communicating policy issues.Excellent transverse collaboration skills, demonstrated ability to work effectively in cross-functional and / or global teams.Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and / or organizational goals.Physical RequirementsThis role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. This position requires the ability to travel independently overnight and / or work after hours as required by travel schedules or business needs.Compensation and BenefitsIn addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923. A new request will need to be submitted for any ADA accommodations after starting employment.Notice for California ApplicantsPlease see our California Applicant Privacy Notice within our Privacy Policy.Notice to Search Firms / Third-Party Recruitment Agencies (Recruiters)The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”).